FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters

The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. It seems the device, which is available over-the-counter, can generate incorrect test results at extremely high blood glucose levels.

Background

The FreeStyle InsuLinx Blood Glucose Meter is an Over-the Counter single patient-use device intended to be used by the patient outside of a health care facility as an aid to monitor the effectiveness of diabetes control.

Part numbers: 71142-70, 71143-70, 71145-70, 71150-70 are affected by this recall (all serial numbers and LOTS). According the FDA recall notice, at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.

Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention. If the FreeStyle InsuLinx Blood Glucose Meter displays an inaccurate low result, there may be a delay in identification and treatment of severe high blood glucose levels (hyperglycemia), or inappropriate treatment may be administered to the patient. This could lead to serious injury or death.

Patients are warned that if they are users of the FreeStyle InsuLinx Meter, they should immediately take one of the following actions to address this issue with your meter:

  • Access a software update to install on your meter to resolve the issue here.
  • Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of the FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter immediately upon request.
  • Until able to update the meter software or until a requested replacement meter arrives, the current FreeStyle InsuLinx meter may be used; however, if the patient experiences symptoms that are not consistent with meter readings, they should contact their health care professional and follow his or her treatment advice. Extremely high blood glucose levels require immediate medical attention.

Healthcare Professionals are advised to immediately discontinue dispensing them to patients. Abbott Diabetes Care customer service can arrange return and replacement at 1-866-723-2697.

  • Abbott Diabetes Care is notifying patients directly; however, they are also requesting assistance from healthcare professionals in sharing this information with patients who use the FreeStyle InsuLinx Meters.

Retailers/Distributors with FreeStyle InsuLinx Blood Glucose Monitoring Kits in current stock, are advised to immediately discontinue distributing this product. Abbott Diabetes Care will replace FreeStyle InsuLinx Blood Glucose Monitoring Kits with products that do not have this issue. To arrange for product return and replacement, please call Abbott Diabetes Care customer service at 1-866-723-2697. While Abbott Diabetes Care is notifying their patients directly, they are also requesting retailer/distributor assistance in sharing this information with customers who use the FreeStyle InsuLinx products.

Source: FDA